K-number	K234065
Device name	CDI OneView Monitoring System
Applicant	Terumo Cardiovascular Systems Corporation
Product code	DRY
Device class	Class II
Decision date	Apr 25, 2024
Decision	Substantially Equivalent
Regulation	870.4330

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Source

View the full FDA submission: accessdata.fda.gov

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CDI OneView Monitoring System

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